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ניווט:

QA&RA Manager Medical device company

JB-598

מספר משרה:

שרון

איזור:

מלאה

היקף:

Implementation of a culture of quality
Compliance with regulatory requirements and international standards, including ISO 13485, 21 CFR 820, EU-MDR 2017/745
- Preparation of annual quality plans in collaboration and oversight of their implementation (these plans may include initiatives for improving quality infrastructure, responding to new regulatory requirements/standards, etc.)
- Management of the quality department: QC personnel and quality engineers
- Professional guidance of all quality functions within the company, such as training, configuration management, supplier controls, incoming inspection, calibrations, customer complaints, CAPA, documentation controls etc.
- Conducting quality training within the company
- Leading quality audits (customer audits, regulatory bodies, and internal audits)
- Leading management reviews
- Defining quality goals and metrics in collaboration with management and defining improvement activities as needed.

תאור משרה:

- Engineering or science academic degree
- Certified Quality Engineer (ICQE/CQE, with preference for certification from the American Society for Quality)
- Minimum of 5 years of experience in QA&RA management of medical device
- Certified Medical device lead auditor (advantage)
- Strong leadership and management skills
- Excellent interpersonal skills, communication ability, leadership of managers and employees, integrity, and reliability.

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